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NCT03040687 · ClinicalTrials.gov registry record · Phase 1
Efficacy of B7A BSIgG Against E. Coli Strain B7A Challenge
A Phase 1 study of Healthy Volunteer, sponsored by Johns Hopkins Bloomberg School of Public Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT03040687: Completed Phase 1 study of Healthy Volunteer, sponsored by Johns Hopkins Bloomberg School of Public Health.
NCT03040687 is a Phase 1 study of Healthy Volunteer that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 60 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03040687, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Johns Hopkins Bloomberg School of Public Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Enterotoxigenic Escherichia coli (ETEC) is a major cause of diarrhea worldwide. Vaccines and therapeutics are under development to prevent ETEC disease in children and travelers. One approach is to use passive protection (antibodies) to prevent infection. The purpose of this study are to assess the safety of serum-derived bovine immunoglobulins in healthy adult subjects when orally administered and to estimate protective efficacy of those preparations against moderate-severe diarrhea upon challenge with the ETEC strain B7A.
Primary Outcome
Number of Participants with adverse events in groups receiving B7A- and CS6- hyperimmune (BSIgG) compared with the group receiving the nonhyperimmune product.
Conditions Studied
Interventions
- BIOLOGICAL Anti CS6 BSIgG product (Lot PD1601105CS)
- BIOLOGICAL Anti B7A BSIgG product (Lot PD1601132ET)
- BIOLOGICAL Bovine Immunoglobin Negative Control (Lot PD161071NC)
- BIOLOGICAL B7A- CS6-expressing ETEC challenge strain
Study Locations (1)
Maryland
- Johns Hopkins Center for Immunization Research - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-01 |
| Est. Completion | 2017-08 |
| Phase | Phase 1 |
What the finished NCT03040687 record still lists
NCT03040687 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 4 interventions - of which Anti CS6 BSIgG product (Lot PD1601105CS) is the first listed.
NCT03040687 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03040687 about?
NCT03040687 is a clinical study titled "Efficacy of B7A BSIgG Against E. Coli Strain B7A Challenge". Enterotoxigenic Escherichia coli (ETEC) is a major cause of diarrhea worldwide. Vaccines and therapeutics are under development to prevent ETEC disease in children and travelers. One approach is to use passive protection (antibodies) to prevent infection. The purpose of this study are to assess the ...
What is the current status of trial NCT03040687?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2017-01. Estimated completion is 2017-08.
What conditions does trial NCT03040687 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT03040687?
The interventions under investigation include: Anti CS6 BSIgG product (Lot PD1601105CS) (BIOLOGICAL), Anti B7A BSIgG product (Lot PD1601132ET) (BIOLOGICAL), Bovine Immunoglobin Negative Control (Lot PD161071NC) (BIOLOGICAL), B7A- CS6-expressing ETEC challenge strain (BIOLOGICAL).
Who is sponsoring clinical trial NCT03040687?
This trial is sponsored by Johns Hopkins Bloomberg School of Public Health, which has 187 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03040687 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03040687's enrollment target sits among peer trials
60 55th of 112 higher than 58 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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